Comparison of Two Early Treatments for Premature Babies and Their Effects Over Time

NCT07261046 | Not Yet Recruiting

• 1 other identifier: PREMOTSENS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

According to the latest World Health Organization report, prematurity is a major health issue, recognized as a significant vulnerability factor contributing to the emergence of neurodevelopmental disorders. Of the various approaches adopted to limit its consequences, the control of the sensory environment and sensory-focused care are relatively recent. Although a number of sensory care approaches exist, few of them address the different sensory modalities jointly and have been scientifically validated. This research project aims to conduct a study in France on the effectiveness of multisensory ATVV (Auditory, Tactile, Visual, and Vestibular stimulation) treatment using a combination of short- and long-term clinical assessments. The research hypothesis is that ATVV care provided before term age will have a greater impact than "Parental Singing" care on the motor parameters and alertness level of premature infants. Given the importance of motor activity on child development, it is hypothesized here that from term age onwards, the development of children in the ATVV group will be less atypical, or even equivalent to that of the group of full-term infants for most of the parameters evaluated. Furthermore, this normalization of the developmental trajectory will be less pronounced for the "Parental Singing" group. However, the sessions for both treatments (Parental Singing and ATVV) should improve early interactions, sucking, and physiological parameters.

Conditions

Premature Baby 26 to 32 Weeks; Premature - Weight 1000g-2499g or Gestation of 28-37weeks; Premature Baby 33 to 36 Weeks; Premature Between 32 and 36 Weeks of Amenorrhoea

Keywords

ATVV; multisensory care; preterm outcome; sensory integration; NICU

Outcome Measures

Primary Outcomes (1)

• Analysis of the long-term impact of ATVV care on premature infants

  The primary objective is to analyze the long-term impact of ATVV care on premature infants. Motor and cognitive development at 6 months will be compared between premature infants (30 to 34 weeks gestation) receiving ATVV care with premature infants receiving "Singing" care and full-term infants (\>37 weeks gestation), using the Bayley Scales of Infant and Toddler Development, 4th Edition (from 16 days to 42 months) and its motor subscore (assessing fine and gross motor skills) and cognition subscore. A subscore (standardized score) ≥ 85 out of 160 in each domain corresponds to typical development.

  The primary endpoint will be measured at 6 months corrected age in premature infants, and at 6 months in full-term infants.

Secondary Outcomes (10)

• Motor skills

  The outcome is measured between 34 weeks gestational age and 2 months of corrected age.

• Overall and communication development

  The outcome is measured between 34 weeks gestational age and 2 months of corrected age.

• Multisensory integration

  The outcome is measured between 34 weeks gestational age and 2 months of corrected age.

• Level of alertness

  The outcome is measured between 34 weeks gestational age and 2 months of corrected age.

• Precocious interactions

  The outcome is measured between 34 weeks gestational age and 2 months of corrected age.

Study Arms (3)

ATVV group

EXPERIMENTAL

The experimental group comprising premature infants receiving ATVV care

Behavioral: ATVV (Auditory, Tactile, Visual and Vestibular stimulation)

Parental Singing group

OTHER

The intervention control group comprising premature infants receiving Parental Singing care

Behavioral: Singing

Control group

NO INTERVENTION

The control group comprising full-term infants

Interventions

ATVV (Auditory, Tactile, Visual and Vestibular stimulation) BEHAVIORAL

ATVV consists in providing the infant with multisensory stimulation through massage, talking, eye contact, and gentle rocking.

ATVV group

Singing BEHAVIORAL

The singing intervention consists in parents singing softly next to the child's ear.

Parental Singing group

Eligibility Criteria

• Age: 0 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For premature infants: birth between 30 and 34 weeks of gestation plus 6 days, and weighing more than 1800 g at the start of the trial.
• For full-term infants: pregnancy and birth without complications at or after 37 weeks of gestation, with an Apgar score ≥7 at 10 minutes after birth.
• For parents or legal guardians:
• Parents over the age of 18
• Parent agreeing to be filmed with their infant (parent who will be responsible for the treatment)
• Parents capable of understanding the information document
• Parent affiliated with or beneficiary of the French social security system

You may not qualify if:

• For premature infants:
• Birth before 30 weeks of gestation
• Weight less than 1800 g at the start of the trial
• Morbidities related to prematurity (necrotizing enterocolitis, cerebral parenchymal damage, stage III and IV intraventricular hemorrhages)
• Presence of a congenital malformation or chromosomal abnormality
• Known sensory, motor, or central nervous system impairment
• Patient receiving non-invasive ventilation at 34 weeks gestational age (CPAP and high-flow nasal cannula)
• For full-term infants:
• Birth before 37 weeks gestation
• Birth with complications
• For the parent providing the treatment and the infant:
• Presence of a known sensory, motor, or central nervous system impairment
• Presence of a congenital condition
• Presence of psychological distress in the parent
• For both parents:

Sponsors & Collaborators

• Elsan: lead
• Clinique Bouchard: collaborator

Study Sites (2)

Clinique Bouchard

Marseille, France

Location

Hopital Saint-Joseph

Marseille, France

Location

MeSH Terms

Interventions

Touch; Singing

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Phonation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Bellardie

CONTACT

+33 6 59 68 51 43; manon.bellardie@univ-amu.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

FR (2)